MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number D233

Device Problems High impedance (1291); Over-Sensing (1438)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) called technical services (ts) and requested a review of the implantable cardioverter defibrillator (icd) system presenting electrogram (egm).Upon review, ts observed that the patient was in a true ventricular arrhythmia that was converted with shock therapy delivery.However, shortly post shock therapy, the device had recorded a signal artifact monitor (sam) event due to minute ventilation (mv) oversensing noise signals and high within limits impedances exhibited on the right atrial (ra) lead.At this time, the icd device and ra lead remain in service.No additional adverse patient effects were reported.

Event Description

It was reported that the health care professional (hcp) called technical services (ts) and requested a review of the implantable cardioverter defibrillator (icd) system presenting electrogram (egm).Upon review, ts observed that the patient was in a true ventricular arrhythmia that was converted with shock therapy delivery.However, shortly post shock therapy, the device had recorded a signal artifact monitor (sam) event due to minute ventilation (mv) oversensing noise signals and high within limits impedances exhibited on the right atrial (ra) lead.At this time, the icd device and ra lead remain in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to intermittent increases in impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please see the description for more information regarding the specific circumstances of this event.

• Brand Name: VIGILANT EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19164946
• MDR Text Key: 341180646
• Report Number: 2124215-2024-24546
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: 00802526587801
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 635406
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male